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Method of producing heparin calcium from crude heparin sodium

A technology of heparin sodium and heparin calcium, which is applied in the field of biomedicine, can solve the problems of cumbersome operation, high production cost, and high requirements for resin activation, and achieve the effect of high activity quality, low production cost, and easy industrialized large-scale production

Inactive Publication Date: 2018-08-17
HUBEI YINUORUI BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When converting the product from sodium salt to calcium salt, this process uses anion exchange resin, which has high requirements for resin activation, requires a lot of water, cumbersome operation, and high production costs

Method used

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  • Method of producing heparin calcium from crude heparin sodium
  • Method of producing heparin calcium from crude heparin sodium
  • Method of producing heparin calcium from crude heparin sodium

Examples

Experimental program
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Effect test

Embodiment 1

[0031] A method for producing heparin calcium from crude heparin sodium is provided in this embodiment, the method comprising the steps of:

[0032] 1. Weigh 10kg of crude heparin sodium and add 10 times of purified water, stir at 50°C for 2.0 hours and then dissolve; then add 2kg of sodium chloride to the aqueous solution, adjust the pH to 8.0 with sodium hydroxide, then heat up to 43 ℃, stirring and reacting for 3 hours, adding 2kg of calcium chloride, raising the temperature to 85 ℃, keeping warm for 30 minutes, cooling to 60 ℃, filtering to obtain crude heparin sodium salt solution.

[0033] 2. Adjust the crude heparin sodium salt solution in step 1 with hydrochloric acid to pH = 7.0, add 0.8 times of ethanol according to the volume of the feed solution, and separate the mixture after standing for 10 hours;

[0034] 3. Discard the supernatant, and add 180 kg of 10% calcium chloride solution to dissolve the lower sediment;

[0035] 4. Adjust the solution in step 3 with sat...

Embodiment 2

[0042] A method for producing heparin calcium from crude heparin sodium is provided in this embodiment, the method comprising the steps of:

[0043] 1. Weigh 10kg of crude heparin sodium, add 10 times of purified water, and stir at 50°C for 2.0 hours to dissolve; then add 2kg of sodium chloride to the aqueous solution, adjust the pH to 8.2 with sodium hydroxide, and stir to react 3 hour, add 2.0kg of calcium chloride, heat up to 83°C, keep warm for 30 minutes, drop to 60°C, filter to obtain crude heparin sodium salt solution;

[0044] 2. Adjust the crude heparin sodium salt solution in step 1 with hydrochloric acid to pH = 7.0, add 0.8 times of ethanol according to the volume of the feed solution, and separate the mixture after standing for 10 hours;

[0045]3. Discard the supernatant, and add 18 times of 15% calcium chloride solution to dissolve the lower sediment;

[0046] 4. After adjusting the solution in step 3 with saturated calcium hydroxide solution to make the pH to ...

Embodiment 3

[0053] A method for producing heparin calcium from crude heparin sodium is provided in this embodiment, the method comprising the steps of:

[0054] 1. Weigh 10kg of crude heparin sodium and add 12 times of purified water, and stir at 55°C for 1.5 hours to dissolve; then add 3kg of sodium chloride to the aqueous solution, adjust the pH to 8.5 with sodium hydroxide, and stir to react 2 hour, add 3kg of calcium chloride, heat up to 88°C, stir and react for 30 minutes, drop to 60°C, filter to obtain crude heparin sodium salt solution;

[0055] 2. Adjust the crude heparin sodium salt solution in step 1 with hydrochloric acid to pH = 7.0, add 1.0 times of ethanol according to the volume of the feed solution, and separate the mixture after standing for 10 hours;

[0056] 3. Discard the supernatant, and add 200 kg of 15% calcium chloride solution to dissolve the lower sediment;

[0057] 4. After adjusting the solution in step 3 with saturated calcium hydroxide solution to make the p...

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Abstract

The invention discloses a method of producing heparin calcium from crude heparin sodium. The method comprises the steps, such as, with crude heparin sodium as a raw material, salt decomposition, precipitating, dissolving, oxidizing, precipitating, dissolving, oxidizing, precipitating, dissolving, and lyophilizing, and the finished heparin calcium having stable and controllable quality is obtained.The method of producing heparin sodium uses crude heparin sodium as a raw material; calcium conversion is achieved during oxidative cleaning and decoloring by hydrogen peroxide addition; the problemof the prior art is solved that calcium-sodium exchange of cation exchange resin has high resin activation requirement, has the need for massive water and operational complexity and high production cost. The method has the advantages that the production steps are simplified, less impurity is introduced, finish heparin calcium of high purity, high yield, high activity and controllable quality stability can be acquired, the product quality is higher than that provided in existing standards of EP (European pharmacopeia); the method is simple to perform, low in production cost and easy to implement for industrial large-scale production, and has important application prospect.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to a method for producing heparin calcium from crude heparin sodium. Background technique [0002] Antithrombotic drugs include heparin, non-heparin antiplatelet aggregation drugs, enzymes and four other small subclasses. Heparin and enzymes are basically biochemical drugs. Among them, heparin occupies the largest market share. Bioactive heparin has been in clinical use for nearly a hundred years since it was discovered. It is the drug of choice for preventing postoperative thrombosis and treating acute venous thrombosis. In addition, heparin and its derivatives are also widely used in regulating blood lipids, anti-inflammation, anti-allergy and immune regulation, etc. So far, it is still one of the most important biochemical drugs, and it is also one of the main foreign exchange-earning drugs exported in my country. [0003] Among the heparins, heparin drugs dominate, and low molecular ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/10
CPCC08B37/0003C08B37/0075
Inventor 董凯干浩张庆华韩自江黄珑罗锡川何锐倪爱民汤恒义
Owner HUBEI YINUORUI BIOLOGICAL PHARMA
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